MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE4 9MM CM

Model Number	202-01-104
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.
Event or Problem Description
Revision surgery: patient presented 5 years post operation with pain due to laxity.The surgeon suspected poly wear.However intraoperatively it was discovered that all components were secure, free from any defect and there was very minimal poly wear.Surgeon felt a thicker poly would benefit the patient.Replaced 9mm with a 15mm.
Additional Manufacturer Narrative
Corrected data: see d.1., d.2., d.4., d.11.& g.5.Manufacturer narrative: the reason for this revision surgery was reported as pain.The previous surgery and the surgery detailed in this event occurred 4 years and 11 months apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain.There were no findings during this evaluation that indicate the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, degenerative bone disease, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE4 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9681595
• Report Number: 1644408-2020-00042
• Device Sequence Number: 3135475
• Product Code: JWH
• UDI-Device Identifier: 00888912109383
• UDI-Public: (01)00888912109383
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 202-01-104
• Device Catalogue Number: 385-09-504
• Device Lot Number: 59604414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 120-01-032 LOT 469A1070.; 324-01-104 LOT 233B1172.; 385-09-504 LOT 59604414.; 120-01-032 LOT 469A1070; 324-01-104 LOT 233B1172; 385-09-504 LOT 59604414
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR